Leuprolide; Norethindrone

March 21, 2017

Leuprolide Acetate Suspension for injection, Norethindrone Acetate Oral tablet

What is this medicine?

LEUPROLIDE; NORETHINDRONE (loo PROE lide; nor eth IN drone) is a combination of 2 medicines that help to treat endometriosis in women. Leuprolide is an injection that acts like a natural hormone in the body. Norethindrone is a tablet that is a female hormone.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • breast, cervical, or vaginal cancer

  • depression

  • diabetes

  • heart disease

  • high blood pressure

  • high cholesterol

  • history of blood clots

  • history of stroke

  • kidney disease

  • liver disease

  • migraine

  • osteoporosis

  • seizures

  • smoke tobacco

  • unusual vaginal bleeding

  • an unusual or allergic reaction to leuprolide, norethindrone, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Leuprolide is for injection into a muscle. It is given by a health care professional in a hospital or clinic setting.

Take the norethindrone tablets by mouth with a glass of water. You may take it with or without food. Follow the directions on the prescription label. Take this medicine at the same time each day. Do not take your medicine more often than directed.

A patient information sheet will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

For the leuprolide injection: Keep your appointments for follow-up doses as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

Norethindrone tablets: If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • amprenavir or fosamprenavir

  • bosentan

  • chasteberry

This medicine may also interact with the following medications:

  • antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines

  • aprepitant

  • barbiturate medicines, such as phenobarbital

  • carbamazepine

  • felbamate

  • herbal or dietary supplements, like black cohosh or DHEA

  • modafinil

  • oxcarbazepine

  • phenytoin

  • ritonavir or other medicines for HIV infection or AIDS

  • St. John's wort

  • topiramate

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Talk to your doctor about using a method of birth control that does not contain hormones.

Using this medicine for a long time may increase your risk of low bone mass. Do not use for more than 2 six-month treatments. Talk to your doctor about bone health.

If you have any reason to think you are pregnant, stop taking this medicine right away and contact your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breast swelling, tenderness

  • breathing problems

  • changes in vision

  • depressed mood

  • loss of memory

  • pain in your legs or groin

  • severe headache

  • shortness of breath, chest pain, swelling in a leg

  • stomach pain

  • swelling of the feet and legs

  • unusually weak or tired

  • vaginal infection

  • visual changes

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

  • anxious

  • change in menstrual flow

  • constipation

  • hot flashes

  • irritable

  • loss of appetite

  • muscle pain

  • nausea

  • pain, redness, or irritation at site where injected

  • skin problems or acne

  • trouble sleeping

  • weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store the norethindrone tablets at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Leuprolide injection is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.


March 21, 2017


U.S. FDA-approved Package Insert